The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Vertex Pharmaceuticals' Kalydeco (ivacaftor) to treat the underlying cause of cystic fibrosis (CF).
Kalydeco is indicated for people with CF who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene.
Vertex Global Research and Development chief scientific officer and executive vice president Peter Mueller said, "We look forward to working with the European Medicines Agency to bring KALYDECO, our first new medicine in Europe, to people with CF as quickly as possible."
The positive findings from two global Phase III studies, which kalydeco demonstrated unprecedented improvements in breathing and other measures of disease for people ages six and older with the specific genetic mutation, were the base for CHMP opinion.
The European Commission, which has the authority to approve medicines for the European Union, will review the CHMP's positive opinion.
